ALLOPURINOL-ARX allopurinol 100mg tablet bottle

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

allopurinol, Quantity: 100 mg

Tillgänglig från:

Arrotex Pharmaceuticals Pty Ltd

INN (International namn):

Allopurinol

Läkemedelsform:

Tablet, uncoated

Sammansättning:

Excipient Ingredients: povidone; maize starch; lactose monohydrate; stearic acid

Administreringssätt:

Oral

Enheter i paketet:

200 tablets

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

INDICATIONS AS AT 6 February 2003: Main clinical manifestations of urate/uric acid deposition. These are gouty arthritis, skin tophi and/or renal involvement through crystal deposition or stone formation. Such clinical manifestations may occur in: idiopathic gout; uric acid lithiasis; acute uric acid nephropathy; neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously or after cytotoxic therapy, certain enzyme disorders which lead to overproduction of urate and involve: hypoxanthine guanine phosphoriboslytransferase including Lesch-Nyhan syndrome, glucose 6-phosphatase including glycogen storage disease, phosphoribosylpyrophosphate synthetase, phosphoribosylpyrophosphate amidotransferase. ALLOPURINOL-ARX is indicated for the management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to deficient activity of adenine phosphoribosyl transferase. ALLOPURINOL-ARX is indicated for the management of recurred mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed.

Produktsammanfattning:

Visual Identification: White, biconvex round tablets, one side embossed with 'AP' and '100' separated by a break line and plain on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius

Bemyndigande status:

Licence status A

Tillstånd datum:

2017-05-03

Bipacksedel

ZYLOPRIM- Consumer Medicine Information
Page 1 of 4
ZYLOPRIM™
TABLETS
_allopurinol _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
ZYLOPRIM (Allopurinol tablets).
It does not contain all of the
available information about
ZYLOPRIM tablets.
It does not replace talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you or your child taking
ZYLOPRIM against the benefits he
or she expects it will have.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT IS ZYLOPRIM
The name of your medicine is
ZYLOPRIM and is available in
tablets of two different strengths.
The active ingredient is called
allopurinol.
_ _
Allopurinol_ _belongs to a group of
medicines called anti-uricaemic
agents and is used to reduce the
amount of uric acid in the body.
Most commonly, high levels of uric
acid in the body are related to gout.
ZYLOPRIM is available as a 100
mg and 300 mg tablet.
WHAT ZYLOPRIM IS USED
FOR
ZYLOPRIM is used to treat high
levels of uric acid in the blood
(hyperuricaemia) associated with
gout or some other conditions.
Your doctor will identify these other
conditions if necessary, as they are
very uncommon (e.g. Lesch-Nyhan
Syndrome).
Your doctor however, may have
prescribed ZYLOPRIM for another
purpose not listed above.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ZYLOPRIM
HAS BEEN PRESCRIBED FOR YOU.
If you have any concerns, you
should discuss this with your
doctor.
This medicine is only available with
a doctor’s prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
Do not take ZYLOPRIM if you are
allergic to:
•
Allopurinol or any of the
ingredients listed at the end of
this leaflet including lactose.
Some of the symptoms of an
allergic reaction to ZYLOPRIM may
include urticaria and other skin
rashes, difficulty breathing, hay
fever, swelling of the face or throat
or faintness.
D

Produktens egenskaper

1
AUSTRALIAN PRODUCT INFORMATION – ALLOPURINOL-ARX
(ALLOPURINOL) TABLETS
1
NAME OF THE MEDICINE
Allopurinol.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ALLOPURINOL-ARX tablets contain 100 mg or 300 mg allopurinol.
Excipients with known effect: lactose monohydrate. For the full list
of excipients, see Section 6.1 LIST
OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ALLOPURINOL-ARX 100 mg tablets are white, biconvex round tablets, one
side embossed with ‘AP’
and ‘100’ separated by a break line and plain on the other side.
ALLOPURINOL-ARX 300 mg tablets are white, biconvex round tablets, one
side embossed with ‘AP’
and ‘300’ separated by a break line and plain on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Main clinical manifestations of urate/uric acid deposition. These are
gouty arthritis, skin tophi
and/or renal involvement through crystal deposition or stone
formation. Such clinical
manifestations may occur in: idiopathic gout; uric acid lithiasis;
acute uric acid nephropathy;
neoplastic disease and myeloproliferative disease with high cell
turnover rates, in which high urate
levels occur either spontaneously or after cytotoxic therapy, certain
enzyme disorders which lead to
overproduction of urate and involve:
•
hypoxanthine guanine phosphoribosyltransferase including Lesch-Nyhan
syndrome,
•
glucose 6-phosphatase including glycogen storage disease,
•
phosphoribosylpyrophosphate synthetase,
•
phosphoribosylpyrophosphate amidotransferase.
2
ALLOPURINOL-ARX is indicated for the management of
2,8-dihydroxyadenine (2,8-DHA) renal stones
related to deficient activity of adenine phosphoribosyl transferase.
ALLOPURINOL-ARX is indicated for the management of recurrent mixed
calcium oxalate renal stones
in the presence of hyperuricosuria, when fluid, dietary and similar
measures have failed.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The dosage should be adjusted by monitoring serum urate concentrations
and urinary urate/uric
acid levels at appropriate intervals.
DOSE FREQUENCY
ALLOPURI